Approaching DoE During Process Characterization

Michael Tracey is a Research Fellow in Science & Technology at Cambrex Charles City, IA. He holds a B.S. in Chemistry from Denison University and a Ph.D. in Chemistry from the University of Minnesota, and completed a postdoctoral fellowship at Stanford University. He is the author of 16 peer-reviewed papers and four patents.

With more than 19 years in the pharmaceutical industry across both biotech and CDMO organizations, he has held process chemistry roles and mentored four postdoctoral fellows at Cambrex. His expertise spans process chemistry, technology transfer, validation enabling studies, design of experiments, and mentorship.

On how Cambrex approaches design of experiments during process characterization, Tracey grounds the answer in validation expertise. That depth, he suggests, is what allows his teams to problem-solve their way to the right approach — determining how best to optimize and validate a given process so a client can bring their drug to market.